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FDA Issues Final Guidance Document

for Testing Living Donors Using WNV NAT

Bulletin 16-15

September 13, 2016

Yesterday, the Food and Drug Administration (FDA) released a final guidance document that describes recommendations to use a Nucleic Acid Test (NAT) for West Nile Virus (WNV) for testing, with few exceptions, living donors of human cells, tissues, and cellular and tissue-based products (HCT/Ps). The document can be downloaded at the following link:

Use of Nucleic Acid Tests to Reduce the Risk of Transmission of West Nile Virus from Living Donors of Human Cells, Tissues, and Cellular and Tissue-Based Products (HCT/Ps); Guidance for Industry (PDF - 96KB)

Posted 9/12/2016

The guidance provides a comprehensive overview of knowledge regarding WNV in the United States (U.S.) and includes this statement: "However, for certain emerging infectious diseases such as WNV, testing living donors only may be both practical and adequate to reduce the transmission by HCT/Ps." The guidance contains recommendations for test kits to use and for interpreting test results, there are specific recommendations for semen donors, and recommendations differ for establishments located within the U.S. (seasonal testing) versus those located outside the U.S. (year-round testing). FDA recommends implementation as soon as feasible, but not later than 6 months after the final guidance issuance date. These recommendations apply to all HCT/Ps recovered on or after the implementation date.

To adequately and appropriately reduce the risk of transmission of WNV by HCT/Ps from living donors, the final guidance document recommends:

A. Living HCT/P donors should be tested for WNV using an FDA-licensed NAT donor screening test 3,4.

  1. For establishments located within the United States (includes the 50 states and District of Columbia), we recommend performing WNV testing on HCT/Ps recovered from June 1st through October 31st every year.

    Note: In the case of a repeat semen donor from whom a specimen has already been collected and tested, and for whom retesting is required under 1271.85(d), you are not required to collect a donor specimen at the time of each donation (1271.80(b)(2)). However, you should collect a specimen for WNV NAT testing at the time of (or within 7 days before or after) the first donation that is recovered within the June 1st through October 31st testing period, even if an earlier specimen was already collected and tested.

    Due to the increased potential for donors to contract WNV infection from June 1st through October 31st establishments may want to consider collecting a specimen for WNV NAT testing at the time of (or within 7 days before or after) each donation made during this time period. Although this additional testing for subsequent donations is not required, any reactive results must be considered when making a donor eligibility determination.

  2. For all other establishments not specified above, and intending to import HCT/Ps into the United States, testing of HCT/P donors for WNV should be performed year-round

B. Any HCT/P donor whose specimen tests negative (or nonreactive) for WNV NAT should be considered to be negative (or nonreactive) for WNV for purposes of determining donor eligibility.5

C. Any HCT/P donor whose specimen tests positive (or reactive) for WNV must be considered ineligible to donate (21 CFR 1271.50(b)(2), 1271.80(d)(1)).

(see the final guidance for details provided at notations 3, 4 and 5)

FDA-licensed donor screening tests for WNV NAT can be found here. Note that specimen collection types can differ between test kits.

In December 2015, the AATB requested comments from membership when the draft of this guidance was published (see AATB Bulletin #15-20) but no comments were received. The AATB's Standards Committee will begin to address these recommendations and an announcement of changes to the Standards for Tissue Banking will be forthcoming.